—#83991

Product

Boston Scientific HydroThermAblator Endometrial Ablation System- HTA System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (5/bx) Material/UPN/Catalog Number: M006560201 System-HTA System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (ea) Material/UPN/Catalog Number: M006560200 Intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete.

FDA product code: MNB — Device, Thermal Ablation, Endometrial
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P000040
Affected lot / code info: Lot Numbers: 35421, 35422, 35423, 35424, 35425, 35426, 35846, 35847, 35890, 35891, 35892, 36038, 36039, 36040, 36041, 36042, 36047, 36048, 36104, 36105, 36141, 36142, 36143, 36146, 36147, 36148, 36214, 36215, 36234,36235, 36249, 36250, 36251, 36260, 36261 ,36370, 36371, 36372, 36467, 36468, 36682, 36683, 36684, 36685, 36686, 36688, 36689, 36690, 36693, 36694, 36695, 37049, 37098, 37099, 37149, 37150, 37151, 37154, 37192, 37218, 37219, 37220, 37221, 37222, 3and 7223.

Why it was recalled

Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks and loss of a cervical seal that are responsible for burns.

Root cause (FDA determination)

Process design

Action the firm took

Boston Scientific issued an Urgent Medical Device Recall - Immediate Action Required notification to hospitals and distributors dated July 31, 2009 via Federal Express and requested the immediate discontinued use and segregation of Recall product for return and Complete and return the Reply Verification Tracking Form. An email was sent to Physicians to provide the recall information. Boston Scientific issued a Clarification letter dated August 6, 2009 via Federal Express as a follow-up to the July 31, 2009 Recall letter for the following reason: customers may remove product from the outer box and store it on the inventory shelf by the inner package only. If this is a practice at the facility, a customer must consider both the inner and outer packaging product codes when searching for affected recalled product as the UPN numbers on the inner and outer labeling are different. A reply verification tracking form for customers was provided in case they have located any additional product to return.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Worldwide Distribution -- USA, Austria, Denmark, Finland, France, Great Britain, Italy, Netherlands, and Sweden.

Timeline

Recall initiated: 2009-07-31
Posted by FDA: 2009-09-22
Terminated: 2011-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83991. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.